Tolerability Study of Liquid Metformin (100 and 250 mg/mL) vs IR Tablets
ConditionHealthy Volunteers
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorAspargo Labs, Inc
This is an open-label, randomized study evaluating the tolerability of two concentrations of liquid metformin formulations (100 mg/mL and 250 mg/mL) compared with standard immediate-release metformin tablets in healthy adult subjects. Each participant will receive single oral doses of study treatments in a randomized sequence. Safety and tolerability will be assessed through adverse event monitoring, gastrointestinal symptom evaluations, vital signs, clinical laboratory tests, and ECGs.
Male or female adults 18 to 55 years of age, inclusive.
Known hypersensitivity or contraindication to metformin or any excipients in the study formulations.